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Follow on Google News | Michael Siem of Farney Daniels LLP to Speak at KG’s Product-Hopping EventFor further details, please visit: http://theknowledgegroup.org/ About Michael Siem Michael Siem is a Shareholder at Farney Daniels, PC. and founder of the firm’s New York office. As Head of the firm’s Life Sciences practice, Mr. Siem’s work is focused primarily on pharmaceutical litigation related to the Hatch-Waxman Act. In addition to his Hatch-Waxman practice, he has also litigated cases in various technologies including potential anticancer drugs, agricultural, and medical devices. Over the last several years, Mr. Siem has appeared before various federal district courts and litigated cases in many technological areas, including pharmaceuticals, chemical processes, and biotechnology. Mr. Siem’s practice includes representation of both patentees and alleged infringers. Mr. Siem’s experience encompasses every aspect of litigation, beginning with the presuit investigation and continuing through trial. Mr. Siem is an Adjunct Professor of Law for IIT Chicago-Kent College of Law, teaching a Masters-level course entitled Acquiring Intellectual Property. About Farney Daniels LLP An impressive array of prominent corporations, innovative start-ups, and pioneering individual innovators trusts the lawyers at Farney Daniels to handle a wide range of complex, high-stakes intellectual property cases. This diverse collection of clients appreciates that our attorneys combine decades of large firm experience with the nimbleness and creativity of a small, entrepreneurial law firm. In large part because we offer cutting-edge work set in the congenial collegiality of a litigation boutique, we attract the top notch legal talent required to deliver consistently the skill, insight, attention to detail, and value our clients expect from their counsel. Our attorneys have successfully handled myriad matters involving huge potential damages and possibly-crippling injunctions in federal district and appellate courts across the nation, and before the International Trade Commission, as well as the Federal Trade Commission. Nonetheless, we recognize that every matter is important to our clients; thus we bring the same level of care and effort to each endeavor entrusted to the firm, regardless of size. Event Synopsis: The Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) and other patent laws help pharmaceutical companies retain and extend patents for branded drugs that take decades and vast amounts of money to develop. However, the same Act promotes price competition by allowing generic drug manufacturers to obtain expedited approval for generic versions of previously approved branded drugs by using an Abbreviated New Drug Application (ANDA) that may reply upon clinical trial and other costly data produced by branded drug companies. Branded drug companies naturally want patent exclusivity to last as long as possible. However, extending a period of market dominance without patent or regulatory protection is tantamount to antitrust. To avoid this issue, a recent practice of the branded drug companies is ‘Product Hopping’ or ‘Product Switching’ In this process, the form of drug dispersal is changed (e.g., tablet to a capsule) or the dosage is altered to prevent a generic company from relying on the streamlined ANDA based on the branded manufacturer’ In the case of Abbott Laboratories v. Teva Pharmaceuticals, Abbott and a partner twice changed the previously approved formulation for a drug; thereby delaying generic approval. Complaints alleged that Abbott and co-conspirators violated Sections 1 and 2 of the Sherman Act. Citing Berkey Photo v. Eastman Kodak (1979), a Delaware ruled that even though the innovation harmed competitors, it didn’t decrease competition and therefore did not violate the antitrust laws denied their motion to dismiss. The antitrust implications of product-hopping remain far from clear. A product-hopping claim may survive motion to dismiss if it alleges wrongful action and changing the form of the branded drug. In this two-hour LIVE webcast, a panel of distinguished professionals and thought leaders assembled by The Knowledge Congress will review and discuss the possible Antitrust Implications of Product-Hopping in the Pharmaceutical industry. In a two-hour LIVE Webcast, the speakers will discuss: · Product-Hopping – An Overview · Possible Antitrust Issues and Implications · Antitrust Cases: o Abbott Laboratories v. Teva Pharmaceuticals o Walgreen v. AstraZeneca Pharmaceuticals o Mylan Pharmaceuticals v. Warner Chilcott o Namenda case in the Second Circuit · FTC’s Amicus Brief in 2012 · Potential Risks and Antitrust Violations · Up-to-the-minute Regulatory Updates About The Knowledge Group, LLC/The Knowledge Congress Live Webcast Series The Knowledge Group, LLC was established with the mission to produce unbiased, objective, and educational live webinars that examine industry trends and regulatory changes from a variety of different perspectives. The goal is to deliver a unique multilevel analysis of an important issue affecting business in a highly focused format. To contact or register to an event, please visit: http://theknowledgegroup.org/ End
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